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OpenTrials
Completed

NCT Number: NCT01497912

Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes

Patients with type 1 diabetes are at increased risk of vascular complications both in the micro- and macrocirculation. Hyperglycemia plays a major role in the development of these vascular complications, but other factors such increased platelet adhesion and aggregation, elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin generation, dyslipidemia and endothelial dysfunction may contribute.

Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and vasculature that are independent of their lipid-lowering properties.

The aim of the present study was to investigated the effects of intensive LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia. Furthermore, the effects of atorvastatin therapy on skin microvascular function was also investigated.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, 182 88, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes
  • level of plasma LDL-cholesterol >2.5mmol/L and/or total cholesterol >4.5mmol/L

Exclusion criteria

  • History of macrovascular events

Treatment and study plan

atorvastatin

Drug

Atorvastatin 80mg once daily for 8 weeks

Placebo

Drug

Placebo tablet once daily for 8 weeks

Primary outcomes

  1. Fibrin network permeability

    Time frame: 8 weeks

Secondary outcomes

  1. platelet and endothelial microparticles

    Time frame: 8 weeks

  2. skin microvascular reactivity

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Dec 23, 2011
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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